1. Background Of The Invention
The present invention relates in general to hospital surgery room equipment and specifically to a replacement handle for a surgical room light fixture and a disposable cover for use with the replacement handle.
2. Description Of The Related Art
A sterile environment must be established and maintained in an operating room. Everything which is in the operating room sterile field must be sterilized. Certain reusable items are sterilized after each use, which may be very expensive and troublesome. As a result, it is frequently more economical to use disposable sterile items as opposed to sterilizing reusable items.
Unfortunately, it is neither practical nor economical to dispose of large operating room fixtures, such as lighting fixtures, after each operation. Since any item which is touched by any person who enters the sterile field of an operating room must be sterilized, there must be a way of maintaining the sterility of such large fixtures. Alternatively, steps must be taken to prevent surgical personnel from contacting non-sterile portions of such fixtures that are outside the sterile field of an operating room.
Operating room light fixtures are provided with reusable handles for use by surgical personnel to adjust the angle of incidence upon the operating areas or to bring the light closer to the area which is being operated on during surgery. The lighting fixture handle is normally situated in the middle of the light housing and depends therefrom. Since the handle is being constantly manipulated by surgical personnel during surgery, it must be maintained sterile. Surgical personnel must also be prevented from contacting other portions of the lighting fixture other than the sterile handle. These other portions are non-sterile and are not likely to be sterilized because they are outside the sterile field of an operation. There are currently a number of attempts to address these problems.
First, removable handles of operating room light fixtures are provided so that, in between operations, the handles may be removed and sterilized prior to the next operation. However, this is particularly disadvantageous because it requires very expensive personnel time to sterilize the equipment, expensive materials to wrap it, and sterilization itself could also be troublesome and costly.
Second, sterile disposable handles are provided and are the disposed of after each operation. Examples of such disposable handles are disclosed in U.S. Pat. Nos. 4,844,252 to Barron et al. and 4,974,288 to Reasner. However, it is rather expensive to replace sets of operating room light fixture handles after each operation, which will increase the cost of the operation to the patient. Further, these handles are bulky, requiring more storage space, which is limited at hospitals, and create more waste to the environment.
Third, due to the high cost of the above two alternatives, sterile disposable covers have been provided for covering an operating room light fixture handle. Examples of such sterile disposable covers are disclosed in U.S. Pat. Nos. 4,605,124 to Sandel et al. and 4,976,299 to Bickelman. However, each of these disposable covers suffers from some drawbacks.
More particularly, U.S. Pat. No. 4,605,124 discloses a disposable cover 18 having a cylindrical grip 24 and integral flange 28, and shaped in a manner to surround and fit the corresponding portion 29 of the handle 20. The flange 28 may either be flat-shaped or bell.TM.shaped, depending on the corresponding shape of the handle. Adhesive can be applied to the interior portions of the flange 28 in order to firmly attach the cover 18 to the handle 20. This patent also discloses an adapter kit for adapting the handle cover for use with the light fixture. The adapter kit comprises an internally and externally threaded bushing 234 and an internally threaded adapter handle 220. The bushing 234 is threaded on its inside to attach to a mating threaded bolt extending from the light fixture. The bushing 234 also has outside threads which are used to attach the bushing 234 to the adapter handle 220.
The disposable cover disclosed in U.S. Pat. No. 4,605,124 suffers from several drawbacks. First, since the flange 28 is flexible and is adapted to the shape of the handle 20, the disposable cover does not have a protective guard which prevents the nurse's or surgeon's hand from sliding past the flange portion 28 and contacting non-sterile portions of the surgical room light fixture. Second, the use of adhesive to firmly attach the cover 18 to the handle 20 is troublesome. Third, due to the flexibility of the flange 28, the nurse's or surgeon's glove may become contaminated while applying the cover to the light handle. Fourth, the cover itself may become contaminated from prior folds while it is being applied over the light handle.
U.S. Pat. No. 4,976,299 discloses a sterile disposable cover 11 having a cylindrical hollow member 12 and a guard 13. The guard 13 acts to prevent a surgeon's hand from contacting non-sterile portions of a light fixture. The cover 11 also includes a retention number 17 which partially closes the opening of an opened end 15. The retention number 17 may be a circular plastic disk which is adhered within an annular recessed portion 18 in the guard 13. However, referring to FIG. 1 of this patent, the disposable cover 11 of this patent suffers from the drawback that the guard 13 appears to be flexible and is adapted to the shape of the handle and/or light fixture. Thus, it is possible that the surgeon's hand may slide past the guard 13 and contact non-sterile portions of the light fixture. In addition, the retention disk 17 inhibits the application of the cover to the corresponding handle.